510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

B.T.I. Biotechnology Institute, S.L.

Miñano Alava, ES

B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. appears in FDA device records in Miñano Alava, ES. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for B.T.I. Biotechnology Institute, S.L. between 2003 and 2024. The busiest year on record is 2006, with 2. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for B.T.I. Biotechnology Institute, S.L., by decision year
YearClearances
20031
20051
20062
20071
20091
20101
20161
20181
20211
20222
20232
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240262BTI Interna 3.0 Dental Implant System UnicCa®DZESubstantially Equivalent
K232750BTI Interna Prosthetic ComponentsNHASubstantially Equivalent
K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsNHASubstantially Equivalent
K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsNHASubstantially Equivalent
K211952BTI Interna Narrow/Plus Dental Implant System UnicCaDZESubstantially Equivalent
K202825BTI Extra-Short Dental Implant System UnicCaDZESubstantially Equivalent
K173257BTI Dental Implant System UnicCaDZESubstantially Equivalent
K151391BTI Dental Implant System UnicCaDZESubstantially Equivalent
K091387BTI DENTAL IMPLANT 5.5-6.5DZESubstantially Equivalent
K092112BTI DENTAL IMPLANT TINY 2.5-3.0DZESubstantially Equivalent
K070533BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTSNHASubstantially Equivalent
K061383BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPSEJLSubstantially Equivalent
K053355BTI INTERNA DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K051392BTI-SCAN, VERSION 4.0LLZSubstantially Equivalent
K022258B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEMDZESubstantially Equivalent

Registered establishments

FDA registered establishments for B.T.I. Biotechnology Institute, S.L., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30044175973004417597B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.LEONARDO DA VINCI 14, Miñano Alava 01510 ES2026and 23 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets B.T.I. Biotechnology Institute, S.L. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain